U.S. patent number 4,586,505 [Application Number 06/606,762] was granted by the patent office on 1986-05-06 for laryngeal and tracheal stent.
This patent grant is currently assigned to Universal Prosthetics, Inc.. Invention is credited to Robert E. Berktold, Henry W. Lynch, George A. Sisson.
United States Patent |
4,586,505 |
Sisson , et al. |
May 6, 1986 |
Laryngeal and tracheal stent
Abstract
A laryngeal and tracheal stent which can be used to reconstruct
the larynx or trachea consists of an elongated cylindrical stenting
cuff with an independently inflatable retention cuff at the top and
a second independent inflatable retention cuff at the bottom. The
stent also has individual cuff pilot tubes for separately inflating
or aspirating the stenting, top and bottom cuffs, and guide means
for moving the stent into place.
Inventors: |
Sisson; George A. (Chicago,
IL), Berktold; Robert E. (Chicago, IL), Lynch; Henry
W. (Racine, WI) |
Assignee: |
Universal Prosthetics, Inc.
(Racine, WI)
|
Family
ID: |
24429344 |
Appl.
No.: |
06/606,762 |
Filed: |
May 3, 1984 |
Current U.S.
Class: |
606/192;
128/207.14; 128/207.29 |
Current CPC
Class: |
A61F
2/20 (20130101); A61F 2/04 (20130101) |
Current International
Class: |
A61F
2/20 (20060101); A61F 2/04 (20060101); A61B
017/00 () |
Field of
Search: |
;128/344,207.15,342,343
;604/96,97,98,101,104 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Other References
"Surgery of the Upper Respiratory System," William W. Montgomery
(1973 Ed.), pp. 581 to 583 and 592 and 593..
|
Primary Examiner: Recla; Henry J.
Attorney, Agent or Firm: Quarles & Brady
Claims
We claim:
1. A laryngeal or trachael stent consisting essentially of a hollow
cylindrical body of soft medical application material having a
central bore, said body having a first inflatable retention cuff
about the outer periphery of one end and a second inflatable
retention cuff about the outer periphery of the other end, each of
said cuffs being fluid tight and having its own pilot tube for
adding or subtracting fluid, each pilot tube having a proximal end
extending exterior to said hollow cylindrical body and a distal end
which extends through the central bore of said body and
communicates with the interior of each respective cuff, said stent
further including externally extending guide means for guiding the
stent into proper position in a larynx or trachea, said guide means
comprises at least one string which extends through and externally
out of both ends of the central bore, said string being secured to
said hollow cylindrical body, and means associated with said
central bore for blocking fluid flow therethrough.
2. A stent of claim 1 in which the hollow cylindrical body includes
a fluid tight cylindrical chamber which surrounds the central bore
and which is provided with its own pilot tube for adding or
subtracting fluid to said chamber.
3. A stent of claim 2 in which the cylindrical chamber is filled
with an open-celled foam.
4. A method of inserting a stent comprising a hollow cylindrical
body having an inflatable retention cuff at each end and means for
blocking flow through said hollow body, guide means secured to said
body and extending from each end of the body, said method comprises
performing a tracheotomy, inserting one end of the guide means into
the trachea through the tracheotomy, guiding the stent through the
tracheotomy into the trachea to a proper position above the
tracheotomy by use of the guide means and then inflating at least
one of the inflatable retention cuffs to secure the stent in
position closing off the trachea.
Description
FIELD OF THE INVENTION
The present invention relates to a surgical stent. More
particularly, it relates to a stent for use in connection with the
treatment of an injured larynx or trachea.
BACKGROUND OF THE INVENTION
The use of a solid molded silicone rubber stent for use in
reconstructing a larynx is described by Dr. William W. Montgomery
on pages 581 to 592 of his textbook "Surgery of the Upper
Respiratory System" (1973 ed.). The stent is used to support tissue
grafts and to block off flow through the trachea while the larynx
is being reconstructed. The Montgomery stent which is relatively
firm must be sutured in place. Therefore, its removal is quite
traumatic.
There is a need for a laryngeal and/or tracheal stent which does
not have to be sutured in place and which can be readily removed
without trauma.
SUMMARY OF THE PRESENT INVENTION
The primary objects of the present invention are to disclose a new
and unique laryngeal and tracheal stent which can be used to
reconstruct the larynx or trachea.
It is a further object to disclose a laryngeal and tracheal stent
which can be removed without traumatizing the surrounding
tissues.
The stent of the present invention comprises a stenting cuff which
is a cylindrical body of a soft medical application silicone rubber
which is filled with an open celled foam, having a separate and
distinct top or superior retention cuff at the top of the stenting
cuff and a separate and distinct bottom or inferior retention cuff
at the bottom of the stenting cuff. The retention cuffs when
inflated are larger in external diameter than the stenting cuff.
The stenting and retention cuffs are all fluidtight and each cuff
has its own cuff pilot tube which can be used to either aspirate or
inflate the cuff. The stent also includes guide means for guiding
it into the proper position in the trachea. The guide means
preferably comprises at least one string which extends from the top
of the stent, through the stent and out the bottom of the stent.
The string can also be useful to anchor the stent in place.
The stent is indicated for use in conditions which require that the
trachea be separated temporarily from the tissue grafts used to
reconstruct the larynx or trachea after "near total laryngectomy"
or subtotal laryngectomy. Such conditions might be caused by
cancer, injuries to the larynx and trachea or subglottic, glottic
and/or supraglottic stenosis either iatrogenic or congenital.
In the preferred method of the present invention, the stent is
inserted from below the larynx by passing the top guide string
through the tracheotomy, into the trachea, pharynx and out the
nose. Preferably the stent is initially introduced under general
anesthesia, although in some instances it may be introduced under
local anesthesia or as an office procedure. To facilitate
introduction of the stent, the cuffs may first be aspirated to
reduce the external diameter of the stent. The stent is guided into
position by use of the guide strings. When the stent is properly
positioned the retention cuffs are inflated and they retain the
stent in place. The cuff pilot tubes and the guide strings may be
used to anchor the stent in place. The stent may also be inserted
via the mouth and pharynx from above the tracheotomy.
When it is desired to remove the stent the cuffs are aspirated or
deflated. The stent may be removed and inserted by a physician or
by the patient who has been given special training.
BRIEF DESCRIPTION OF THE DRAWING
In FIG. 1 a schematic drawing showing the stent of the present
invention properly positioned in a patient;
FIG. 2 is a longitudinal view, partly in section, of the preferred
embodiment of the stent; and
FIG. 3 is a view taken along lines 3--3 in FIG. 2.
DESCRIPTION OF THE PREFERRED EMBODIMENT
In the preferred embodiment of the invention seen in FIGS. 1 to 3,
the stent 10 includes a cylindrical stenting cuff 11, a top or
superior cuff 12 and a bottom or inferior cuff 13. As seen in FIGS.
2 and 3 the stenting cuff 11 is filled with an open celled foam
14.
The stent, seen in FIGS. 2 and 3, includes a relatively large
central tube 15 which has three separate and distinct lumens 16, 17
and 18 which run longitudinally the length of the tube 15. The top
of the tube 15 and the upper ends of the lumens 16, 17 and 18 are
all sealed by a plug 19. The other or lower ends of the lumens 16,
17 and 18 each communicate with its own separate and distinct cuff
pilot tube 16a, 17a and 18a, respectively. Passageways 11a, 12a and
13a provide communication between the lumens 16, 17 and 18 and the
interior of the fluidtight cuffs 11, 12 or 13, respectively.
As seen in FIGS. 1 and 2, a guide string 20 extends from the above
top of the stent 10 through the lumen 16 of the tube 15 and out the
bottom of the stent. The portion 20a of the guide string 20 which
extends out of the top and the portion 20b which extends out the
bottom of the stent 10 are used to guide the stent into proper
position in the trachea. Portion 20b preferably is connected to the
adapters of the cuff pilot tubes 16a, 17a and 18a to prevent them
from tangling. As seen in FIGS. 1 and 2, the cuff pilot tubes 16a,
17a and 18a are of different lengths and staggered to reduce the
bulk which must be drawn through the larynx.
The stent 10 is conveniently supplied in three sizes, small (12 mm
diameter), medium (14 mm diameter) and large (16 mm diameter). The
stent may be either inserted from above or below the larynx using
the guide string 20. If the stent 10 is inserted from above the
larynx, the bottom cuff 13 and the stenting cuff 11 are first
aspirated and if the stent 10 is inserted from below the larynx,
the top cuff 12 and the stenting cuff are first aspirated. With the
use of the guide string 20, the stent is properly positioned in the
larynx and then the remaining retention cuff is inflated.
As shown in FIG. 1, when the stent 10 is in place the top portion
20a of the guide string 20 extends out the patients nose and the
bottom portion 20b extends out through a tracheotomy. The portions
of the guide string 20 extending outside the body may be used to
anchor the stent 10 in place.
In the preferred practice of the invention, once stent 10 is in
place the top and bottom cuffs 12 and 13 are inflated with saline.
The stenting cuff 11 is not inflated but is allowed to assume its
normal shape at ambient pressure. The position of the stent may be
verified endoscopically at the conclusion of the procedure.
If a patient is thoroughly instructed in the care and maintenance
of the stent, he can remove and, if necessary, replace the stent
himself. A patient familiar with the mechanics of the device can
pull the stent up into his mouth if it becomes dislodged until a
physician can be contacted.
The stent is not designed for pediatric use and should not be
inserted into a larynx which is too small. It is also not to be
used where allergic reaction to the material of the stent may be a
complication.
The stent of the present invention may be used in the same manner
as the Montgomery stent to support graft tissue for reconstruction
of the larynx. However, when the stent of the present invention is
used, it is not necessary to suture the graft to the stent because
the graft will be adequately maintained in position by the
cooperation of the stenting cuff 11, and the sides 12a and 13a of
the top and the bottom retention cuffs 12 and 13, respectively.
Although the preferred material for the components of the stent,
other than the string, is medical grade silicone rubber, any other
suitable biocompatable material may be used provided it functions
in a similar manner. The strings are preferably of Dacron or a
similar biocompatable material.
It will be apparent of those skilled in the art that a number of
changes and modifications may be made in the described stent
without departing from the spirit and scope of the invention. For
example, although in the preferred embodiment both of the retention
cuffs have been described as inflatable another embodiment of the
invention in which the upper retention cuff is filled with foam can
be used, if desired. Therefore, it is intended that the invention
not be limited except by the claims which follow.
* * * * *